Rituximab plus short-duration chemotherapy followed by Yttrium-90 Ibritumomab tiuxetan as first-line treatment for patients with follicular non-Hodgkin lymphoma: a phase II trial of the Sarah Cannon Oncology Research Consortium.

Abstract

PURPOSE:

To evaluate the efficacy and safety of treatment with Yttrium-90 (90Y) ibritumomab tiuxetan following completion of short-course rituximab/chemotherapy in patients with previously untreated follicular non-Hodgkin lymphoma.

PATIENTS AND METHODS:

Forty-one patients with previously untreated follicular lymphoma received rituximab for 4 consecutive weeks, followed by 3 cycles of rituximab combined with either CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone; 88%) or CVP (cyclophosphamide/ vincristine/prednisone; 12%). To complete treatment, all patients received 90Y ibritumomab tiuxetan 4-6 weeks after the final dose of chemotherapy. The primary efficacy endpoint was the clinical complete response (CR) rate after completion of therapy; all patients were followed for progression-free survival (PFS) and overall survival (OS).

RESULTS:

After completion of short-course rituximab/chemotherapy, 95% had objective responses, with a 30% clinical CR rate. The clinical CR rate increased to 72% following 90Y ibritumomab tiuxetan. After a median follow-up of 67 months, the estimated 5-year PFS and OS rates are 64% and 96%, respectively. Reversible grade 3/4 neutropenia and thrombocytopenia occurred in 39% and 36% of the patients, respectively, following 90Y ibritumomab tiuxetan; nonhematologic toxicity was uncommon.

CONCLUSION:

90Y ibritumomab tiuxetan was well tolerated after short-course rituximab/chemotherapy and resulted in a high CR rate and a long PFS. Definitive demonstration of improved efficacy versus rituximab/chemotherapy alone will require a randomized phase III trial.

• Authors: John D Hainsworth, David R Spigel, Tiffanie M Markus, Dianna Shipley, Dana Thompson, Richard Rotman, Charles Dannaher, F Anthony Greco
• Journal: Clinical lymphoma & myeloma (Clin Lymphoma Myeloma) Vol. 9 Issue 3 Pg. 223-8 (Jun 2009) ISSN: 1938-0712 [Electronic] United States
• PMID: 19525191 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived
• Yttrium Radioisotopes
• Rituximab
• ibritumomab tiuxetan
• Vincristine
• Doxorubicin
• Cyclophosphamide
• Prednisolone
• Prednisone

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Cyclophosphamide (administration & dosage, therapeutic use)
• Disease-Free Survival
• Doxorubicin (administration & dosage, therapeutic use)
• Female
• Humans
• Lymphoma, Non-Hodgkin (drug therapy, radiotherapy)
• Male
• Middle Aged
• Prednisolone
• Prednisone (administration & dosage)
• Radioimmunotherapy (methods)
• Rituximab
• Treatment Outcome
• Vincristine (administration & dosage, therapeutic use)
• Yttrium Radioisotopes (pharmacology)